A Blind, Randomized and Controlled Clinical Trial to Evaluate the Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccines for Healthy Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,997
- 试验地点
- 2
- 主要终点
- The protection rate of the vaccine
研究概览
简要总结
The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.
详细描述
This study is a randomized, blind, controlled phase III clinical trial. The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group or control group in the ratio 1:1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer between 1 - 12 years old;
- •Proven legal identity;
- •Guardian(s) of the volunteer and/or volunteers themselves should be capable of understanding the written consent form, and such form should be signed before the volunteer being included into this study;
排除标准
- •Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection;
- •Axillaty temperature > 37.0 °C;
- •History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
- •History of epilepsy, seizures or convulsions, or a family history of mental illness, autoimmune disease or immunodeficiency;
- •Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases;
- •Acute disease or acute stage of chronic disease within 7 days prior to study entry;
- •Receipt of any of the following products:
- •Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- •Any live attenuated vaccine within 1 month prior to study entry;
- •Any blood product, immunosuppressant, hormone, or other investigational medicine(s) within 30 days prior to study entry;
- •Any significant abnormity of heart, lung, skin, or pharynx;
- •Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
研究组 & 干预措施
Experimental Group
- Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
- Intervention: investigational live attenuated varicella vaccine;
干预措施: Investigational live attenuated varicella vaccine (Biological)
Control Group
- Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0;
- Intervention: diluent of lyophilized vaccine;
干预措施: diluent of lyophilized vaccine (Biological)
结局指标
主要结局
The protection rate of the vaccine
时间窗: ≥30 cases reported after 30 days of the injection
The protection rate will be calculated based on the reported cases occurred 30 days after injection.
The incidences of varicella of each group
时间窗: ≥30 cases reported 30 days after injection
The first 30 cases of varicella occurred 30 days after injection will be collected.
次要结局
- The incidences of serious adverse events (SAEs) of each group(6 months)
- The seroconversion rate of the immunogenicity group(30 days after injection)
- The incidences of adverse events (AEs) of each group(30 days)
- The geometric mean titer (GMT) of the immunogenicity group(30 days)
- The geometric mean fold increase (GMI) of the immunogenicity group(30 days after injection)